BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL INC.

    MDR report key: 6818421 · Received August 24, 2017

    Report

    Report Number
    1047429-2017-00003
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    July 26, 2017
    Report Date
    August 24, 2017
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT INCLUDES THE FOLLOWING COMPONENT: LEFT HEART KIT, VENDOR PART # AG8052-NS MANUFACTURED BY ICU MEDICAL INC. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6)2017 ORIGINATED BY (B)(4), RTR, CARDIAC CATH LAB, (B)(6) STATING THAT DURING THE CASE, THEY NOTED BLEED BACK OF BLOOD INTO PR60 MANIFOLD TUBING. THE PRESSURE WAS CHECKED ON THE INFUSOR BAG AND THE LINE WAS FLUSHED AND CLEARED, BUT THEN THE BLEED BACK OCCURRED AGAIN. THE COMPLAINED 3PORT MANIFOLD AND PR60 TUBING WAS SAVED FOR EVALUATION BY THE MANUFACTURER. A PHOTO SHOWING THE BLEED BACK WAS PROVIDED TO AVID. AVID MEDICAL ISSUED FORMAL COMPLAINT #(B)(4) TO THE MANUFACTURER ICU MEDICAL INC. CONCERNING THE BLEED BACK ISSUE FOR ITEM NO. AG8052-NS LEFT HEART KIT WHICH CONTAINED THE COMPLAINED PR60 MANIFOLD TUBING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599556 ICU MEDICAL INC. EXTRAVASCULAR BLOOD PRESSURE TRANSDUCER DRS ICU MEDICAL INC. AG8052-NS 3358731

    Patients

    Seq Age Sex Outcome Treatment
    1